Given the FDA approval of the new botulinum toxin A product, Dysport, in 2009, a competitor to the well establish Botox Cosmetic, the IAPAM recently queried its members and physicians with comprehensive experience in the use of botulinum toxin injectables, to develop a report comparing these two products. This discussion is considered a critical element in the IAPAM’s comprehensive botox training programs. Many physicians want to know the facts of Botox vs Dysport.
Dysport has been studied in Europe since 1988, has been available for use outside the US since 1991, and was recently approved for cosmetic use in the US in May 2009. Equally, Botox has been manufactured and studied in the US since 1985, and was officially approved by the FDA for cosmetic use in April 2002.
Botox ® and Dysport ® are not interchangeable because the products are dosed and injected differently. Expert Botox Training is essential. In support of that training, and to assist physicians in selecting the best product for each patient’s need, the IAPAM has culled comments from a number of physicians offering their expert comparison of Botox ®Cosmetic and Dysport ®.
Instructions for Preparation, Dosage and Administration
Dysport is supplied in a sterile, single-use, 3 mL glass vial. Each vial contains either 300 Units (U) or 500 U of freeze-dried abobotulinumtoxinA; however, only the 300 U vial is approved for the treatment of glabellar lines.
Reconstitution instructions are specific for the 300 U and 500 U vials. Dysport must be reconstituted with 0.9% sterile, preservative-free saline prior to injection.
- Each 500 Unit vial of Dysport is to be reconstituted with 1mL of 0.9% Sodium Chloride Injection USP (without preservative) to yield a solution of 500 Units per mL.
- Each 300 Unit vial of Dysport is to be reconstituted with 0.6 mL of 0.9% Sodium Chloride Injection USAP (without perservative) to yield a solution equivalent to 250 Units per 0.5 mL.
With a syringe and 21-gauge needle and using aseptictechnique, draw up the desired amount of sterile, preservative-free 0.9% saline
|300 U||1.5 mL||10 U/0.05 mL|
|300 U||2.5 mL||10 U/0.08 mL|
|500 U||5.0 mL||10 U/0.1 mL|
Insert the needle into the Dysport vial at a 45º angle and allow the saline diluent to be pulled into the vial by partial vacuum. If the vacuum has been lost, the vial should be discarded.
After adding the diluent, gently rotate (do not shake) the vial until the white substance in the vial is fully dissolved. When fully reconstituted, Dysport should be a clear, colorless, and particulate-free solution.
Once reconstituted, Dysport should be stored in a refrigerator (2-8° C; 36- 46° F), protected from light, and used within four hours. Administer Dysport within 4 hours of reconstitution.
Do not freeze reconstituted Dysport. Discard the vial and needle in accordance with local
regulations. Do not freeze after reconstitution. Discard any remaining solution after injection.
Cost: 300 unit vial in the US is sold to physicians for $475USD*
BOTOX® Cosmetic is to be reconstituted only with 0.9% sterile, non-preserved saline prior to intramuscular injection. Per the dilution table below, draw up the required amount of 0.9% sterile non-preserved sodium chloride solution into a syringe to obtain a reconstituted solution at a concentration of 4 Units/0.1 mL and a total treatment dose of 20 Units in 0.5 mL.
The duration of activity of BOTOX® Cosmetic for glabellar lines is approximately 3-4 months. The safety and effectiveness of more frequent dosing with BOTOX® Cosmetic has not been clinically evaluated and is not recommended.
Reconstituted BOTOX® Cosmetic should be clear, colorless, and free of particulate matter. BOTOX® Cosmetic is supplied as a single use vial. The product and diluent do not contain a preservative. Once opened and reconstituted it should be stored in a refrigerator (2° to 8°C) and used within 24 hours. Discard any remaining solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Do not freeze reconstituted BOTOX® Cosmetic.
|Diluent Added to 100 Unit Vial (0.9% Sodium Chloride Injection Only)||Resulting Dose Units per 0.1 mL||Diluent Added to 50 Unit Vial (0.9% Sodium Chloride Injection Only)||Resulting|
2.5 mL4 Units1.25 mL4 Units
Using a 21-gauge needle and an appropriately sized syringe draw up a total of 2.5 mL/100 Unit vial or 1.25 mL/50 Unit vial of 0.9% sterile saline without a preservative. Insert the needle at a 45° angle and slowly inject into the BOTOX® Cosmetic vial. Discard the vial if a vacuum does not pull the diluent into the vial. Gently rotate the vial and record the date and time of reconstitution on the space on the label.
Draw at least 0.5 mL of the properly reconstituted toxin into the sterile syringe, preferably a tuberculin syringe and expel any air bubbles in the syringe barrel. Remove the needle used to reconstitute the product and attach a 30-33 gauge needle. Confirm the patency of the needle.
Cost: 100 unit vial of Botox Cosmetic® is sold to physicians for over $500USD.
Jennifer Linder, M.D.
“I have tried Dysport® on myself and one staff member, on whom I did as split face. Definitely no faster onset. I personally think, mine which was done full face is wearing off faster and it definitely had a wider diffusion. I do think that due to the dilution ratio and the different technique for injection, using Dysport® is like learning a whole new language as there is no direct conversion.
Because of the variability in the size of the molecules in Dysport® there is variability in the……
To access the rest of this report, please visit our IAPAM ONLY Members Resource Section. If you are not a member, you can join the IAPAM today!
For more information on the IAPAM Aesthetic Medicine Symposium with Botox Training, please call 1-800-219-5108 x704 or e-mail us at: info @ iapam.com
Register for Botox Training Today: 1) Click here to Register On-Line (via Secure form) or 2) Download & Fax RegistrationPlease note: Botox, Botox Cosmetic and Juvederm are registered trademarks of Allergan, Inc. Dysport, Restylane and Perlane are registered trademarks of Medicis, Inc.
About the International Association for Physicians in Aesthetic Medicine (IAPAM)
The International Association for Physicians in Aesthetic Medicine is a voluntary association of physicians and supporters, which sets standards for the aesthetic medical profession. The goal of the association is to offer education, ethical standards, credentialing, and member benefits. IAPAM membership is open to all licensed medical doctors (MDs) and doctors of osteopathic medicine (DOs). Information about the association can be accessed through IAPAM’s website at http://www.IAPAM.com or by contacting:
Jeff Russell, Executive-Director
International Association for Physicians in Aesthetic Medicine (IAPAM)
1-800-219-5108 x705 or email to firstname.lastname@example.org
DISCLOSURE OF UNLABELED USE
This document contains discussion of agents that are not indicated by the U.S. Food and Drug Administration. The International Association for Physicians in Aesthetic Medicine (IAPAM), Allergan, Inc., and Medicis, Inc., do not recommend the use of any agent outside of the labeled indications. The opinions expressed in this document are those of the contributors and do not necessarily represent the views of the IAPAM, Allergan, Inc. or Medicis, Inc.. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Copyright, Legal Notice and Disclaimer
The information presented in this document is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used without evaluation of their patients’ conditions and possible contraindications on dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. This publication is protected under the US Copyright Act of 1976 and all other applicable international, federal, state and local laws, and all rights are reserved, including resale rights: you are not allowed to give or sell this e-book to anyone else. No part of this e_report may be reproduced in any form by any means (including electronic, photocopying, recording, scanning, or otherwise) without prior written permission of the publisher.
Please note that much of this publication is based on personal experience and anecdotal evidence. Although the author(s) and publisher have made every reasonable attempt to achieve complete accuracy of the content in this text, they assume no responsibility for errors or omissions. Also, you should use this information as you see fit, and at your own risk. Your particular situation may not be exactly suited to the examples illustrated here; in fact, it’s likely that they won’t be the same, and you should adjust your use of the information and recommendations accordingly.
Any trademarks, service marks, product names or named features are assumed to be the property of their respective owners, and are used only for reference. There is no implied endorsement if we use one of these terms. Please note that the information presented on these pages is for informational purposes only. The IAPAM (or its affiliates), shall not be liable to anyone for any loss or injury caused in whole or in part by your use of this information, or for any decision you make or action you take in reliance on information you received from this text. This text is not intended to replace legal, medical, accounting or other professional advice, and is only meant to be used as a guideline for the reader. Any information in this publication should not be considered a substitute for consultation with a physician to address individual medical needs.
© Copyright 2009, International Association for Physicians in Aesthetic Medicine. All rights reserved worldwide. Please do not use this material without referencing the IAPAM
Category: Botox Resources